MODIFIED SONAMET BODY COMPOSITION ANALYZER

K032610 · Life Measurement, Inc. · OAC · Mar 1, 2004 · Cardiovascular

Device Facts

• Record ID: K032610
• Device Name: MODIFIED SONAMET BODY COMPOSITION ANALYZER
• Applicant: Life Measurement, Inc.
• Product Code: OAC · Cardiovascular
• Decision Date: Mar 1, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The modified Sonamet Body Composition Analyzer, also known as the PEA POD® Infant Body Composition System (the PEA POD), is indicated for measuring body mass and estimating the body composition (i.e., the body fat and lean body mass) of infants between 1 and 8 kilograms. It is not intended for use with infants requiring life support.

Device Story

PEA POD Infant Body Composition System measures infant body mass and composition; utilizes densiometric approach. Inputs: infant body mass via integrated weighing apparatus; body volume via air displacement plethysmography. Device transforms inputs into density calculations; applies scientific research-derived algorithms to estimate body fat and lean body mass. Housed in movable cart containing reference chamber, calibration volume, air circulation, temperature control, CPU, and printer. Used in clinical settings; operated by healthcare professionals. Output provided via printer/display; assists clinicians in assessing infant nutritional status and body composition. Benefits: non-invasive, accurate body composition assessment for infants.

Clinical Evidence

Bench testing only. Verification testing demonstrated that the device satisfies functional performance requirements safely and accurately.

Technological Characteristics

Densiometric body composition analyzer; utilizes air displacement plethysmography and integrated weighing scale. Components: reference chamber, calibration volume, air circulation system, Air Temperature Control System, CPU, printer. Form factor: movable cart. Software-based algorithm for density and body composition calculation.

Indications for Use

Indicated for measuring body mass and estimating body fat and lean body mass in infants weighing 1 to 8 kg. Contraindicated for infants requiring life support.

Regulatory Classification

Identification

An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Sonamet Body Composition Analyzer (K924972)
• EM-SCAN HP-2 Pediatric Body Composition Analyzer (K902042)

Submission Summary (Full Text)

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MAR - 1. 2004

K032610
page 1 of 2

# Section 6 – 510(k) Summary

# SUBMITTER INFORMATION

Company Name:

Establishment Registration Number:

Company Address:

Company Phone:

Company Facsimile:

Contact Person:

Life Measurement, Inc.

3003873943

1850 Bates Avenue Concord, CA 94520

[phone]

[phone]

Michael Sullivan Vice President of Operations

### DEVICE IDENTIFICATION

| Device Trade Name: | - Modified Sonamet Body Composition Analyzer<br>Note : The trade name for the original Sonamet Body<br>Composition analyzer is currently the “BOD POD”. The<br>modified version will be referred to as the “PEA POD -<br>Infant Body Composition System” when it is introduced into<br>the market. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Generic Name: | Body Composition Analyzer |
| Device Classification: | Classification code: 21 CFR 870.2770<br>Code MNW |
| Classification Panel | Cardiovascular |

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K032610
page 2 of 2

#### IDENTIFICATION OF PREDICATE DEVICES

The modified Sonamet Body Composition System is substantially equivalent to the following devices, which have received FDA clearance:

| Device Name | Manufacturer | K Number |
|--------------------------------------------------------|---------------------------|----------|
| Sonamet Body<br>Composition Analyzer | Life Measurement,<br>Inc. | K924972 |
| EM-SCAN HP-2<br>Pediatric Body<br>Composition Analyzer | EM-SCAN, Inc. | K902042 |

The intended use and technological characteristics of the modified Sonamet Body Composition System are the same as the above predicate devices. Modifications for the pediatric use indication do not raise additional questions regarding safety and efficacy,

#### DEVICE DESCRIPTION

The modified Sonamet Body Composition System ("The PEA POD") is designed to measure the mass and estimate the body composition of infants with body weights ranging between 1 and 8 kilograms, who do not require life support. The PEA POD estimates body composition using a densiometric approach (i.e. by determining the density of the entire body). A weighing apparatus is used to-measure the subject's mass. Air displacement plethysmography is used to measure the subject's volume. Using this data, the subject's density is calculated. The - subject's body composition is then estimated using several algorithms derived from scientific research. The device components are housed in a movable cart, which contains the reference chamber, calibration volume, air circulation system, Air Temperature Control System, electronic components, printer and CPU.

#### INTENDED USE

The modified Sonamet Body Composition Analyzer, also known as the PEA POD® Infant Body Composition System (the PEA POD), is indicated for measuring body mass and estimating the body composition (i.e., the body fat and lean body mass) of infants between 1 and 8 kilograms. It is not intended for use with infants requiring life support.

#### CONCLUSIONS DRAWN FROM STUDIES

The results of verification testing demonstrate that the PEA POD Body Composition Analyzer is substantially equivalent to the predicate devices. Test results indicate that the device satisfies functional performance requirements safely and accurately when used as indicated.

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MAR - 1. 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Life Measurement, Inc. c/o Dr. Sheila Pickering 2081 Longden Circle LOS ALTOS CA 94024

Re: K032610

Trade/Device Name: Modified Sonamet Body Composition Analyzer (PEA POD) Regulation Number: 21 CFR \$870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 78 MNW Dated: January 5, 2004 Received: January 9, 2004

Dear Dr. Pickering:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ins leter will anow you to begin maining of substantial equivalence of your device to a legally premarket notheadon: "The PPP intenty since of the more and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice to: your of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 10. questions of [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general by releveloc to promance nonities under the Act may be obtained from the Division of Strail mornation on your responsibility on the Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdoninal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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## ATTACHMENT 14

### FDA Submission Cover Sheet

510(k) Number: K032610

Device Name: Modified Sonamet Body Composition Analyzer

Indication For Use:

The modified Sonamet Body Composition Analyzer, also known as the PEA POD® Infant Body Composition System (the PEA POD), is indicated for measuring body mass and estimating the body composition (i.e., the body fat and lean body mass) of infants between 1 and 8 kilograms. It is not intended for use with infants requiring life support.

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence Of CDRH, Office Of Device Evaluation (ODE)

Prescription Use

OR Over-The-Counter Use

(Per 21CFR

801)

Nancy C. Broadon

(Division Sign-Off Division of Reproductive. Abde and Radiological Devices 510(k) Number.

143